Drugs / Terbutaline
Terbutaline
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | BRICANYL | — | 1997-10-08 – 2007-12-07 | fda.gov ↗ |
| Approved | US (FDA) | BRICANYL | — | 1974-03-25 | fda.gov ↗ |
Trials 21
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT02178059 | Aug → Nov 2014 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT00607503 | Feb → Sep 2008 | type 1 diabetes mellitus | Jaeb Center for Health Research | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT05494307 | Sep 2022 → Sep 2023 | autoimmune thrombocytopenia | Peking University People's Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04481282 | Jul 2020 → Mar 2021 | autoimmune thrombocytopenia | Peking University People's Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT01582646 | Jan 2012 → Sep 2017 | neuropathy, painful | University Hospital, Strasbourg, France | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04973345 | Jul 2023 → Dec 2026 | asthma | Kanecia Obie Zimmerman | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 36 trials | ||||||
| Phase 3 | NCT06626620 | Jan → Sep 2024 | acute asthma | Muhammad Aamir Latif | Completed | No outcome recorded |
| Phase 3 | NCT01944033 | Jul 2013 → Jul 2016 | chronic obstructive pulmonary disease | University of Monastir | Completed | No outcome recorded |
| Phase 3 | NCT01096017 | Mar → Apr 2010 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00837967 | Jan → Jul 2009 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00244608 | May 2005 → Mar 2007 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00252863 | Dec 2004 → May 2006 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT04527016 | Oct 2021 → Jun 2023 | childhood onset asthma | Children's Hospital of Fudan University | Completed | No outcome recorded |
| Phase 4 | NCT01651962 | Aug 2012 → Jul 2015 | — | Kai Schoenhage | Unknown | No outcome recorded |
| Phase 4 | NCT00124995 | Oct 2003 → Oct 2006 | status asthmaticus | Connecticut Children's Medical Center | Completed | No outcome recorded |
| Phase not applicable6 trials | ||||||
| — | NCT05193968 | Feb 2022 → Dec 2026 expected | — | Mayo Clinic | Recruiting | No outcome recorded |
| — | NCT03565302 | Jun 2018 → May 2021 | hypertrophia musculorum vera | Morten Hostrup, PhD | Unknown | No outcome recorded |
| — | NCT02557581 | Jul 2015 → Jun 2017 | — | University of Copenhagen | Unknown | No outcome recorded |
| — | NCT00974051 | Mar → Dec 2008 | type 1 diabetes mellitus | University of Colorado, Denver | Completed | No outcome recorded |
| — | NCT00518141 | Mar 2006 → May 2009 | — | Sykehuset Telemark | Completed | No outcome recorded |
| — | NCT00214318 | Jan 2005 → Feb 2007 | heart failure | University of Wisconsin, Madison | Completed | No outcome recorded |
| Comparator or background therapy22 trials | ||||||
| Phase 1/2 | NCT04433104 Background | Jun 2020 → Jul 2021 | chronic obstructive pulmonary disease | Vinmec Research Institute of Stem Cell and Gene Technology | Completed | No outcome recorded |
| Phase 2 | NCT00989833 Comparator | Sep 2009 → Jul 2010 | exercise-induced bronchoconstriction | AstraZeneca | Completed | No outcome recorded |
| Phase 2/3 | NCT02115256 Comparator | Jul 2014 → Apr 2015 | — | Yaakov Beilin | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT06980727 Comparator | Aug 2026 → Dec 2027 expected | urinary tract obstruction | University of Monastir | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT04705727 Comparator | Aug → Sep 2021 | childhood onset asthma | Centre Hospitalier Intercommunal Creteil | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT02322788 Comparator | Mar → Nov 2015 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT02224157 Comparator | Nov 2014 → Aug 2017 | asthma | AstraZeneca | Completed | Mixed |
| Phase 3 | NCT02149199 Comparator | Jul 2014 → Aug 2017 | asthma | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT00849095 Comparator | Apr 2009 → Apr 2013 | asthma | Università degli Studi di Ferrara | Completed | No outcome recorded |
| Phase 3 | NCT00839800 Comparator | Feb 2009 → Feb 2011 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00421122 Background | Sep 2006 → Nov 2007 | chronic obstructive pulmonary disease | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT00259766 Background | Apr 2004 → May 2007 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT03106753 Background | Apr 2017 → May 2018 | — | Icahn School of Medicine at Mount Sinai | Terminated | No outcome recorded |
| Phase 4 | NCT00914797 Comparator | Jul 2009 → Mar 2010 | asthma | Bispebjerg Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT00567476 Comparator | Nov 2007 → Apr 2010 | asthma | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00802230 Comparator | Sep 2002 → Dec 2004 | heart failure | University of Utah | Completed | No outcome recorded |
| — | NCT02509299 Background | Sep → Nov 2019 | chronic obstructive pulmonary disease | University of Granada | Completed | No outcome recorded |
| — | NCT05326269 Comparator | Apr 2017 → Sep 2019 | fetal brain disruption sequence | Hospital Kemaman | Completed | No outcome recorded |
| — | NCT02790047 Background | Oct 2016 → Jan 2018 | chronic obstructive pulmonary disease | Khon Kaen University | Unknown | No outcome recorded |
| — | NCT02515318 Comparator | Sep 2015 → Mar 2017 | chronic obstructive pulmonary disease | University of Granada | Unknown | No outcome recorded |
| — | NCT02712658 Comparator | Sep 2015 → Mar 2016 | — | University of Copenhagen | Completed | No outcome recorded |
| — | NCT00185887 Comparator | Oct 2003 → Jul 2006 | fetal brain disruption sequence | Stanford University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2021-01-26 | AstraZeneca | Regulatory Symbicort Turbuhaler approved in China as an anti-inflammatory reliever in mild asthma astrazeneca.com ↗
AstraZeneca’s Symbicort Turbuhaler (budesonide/formoterol 160/4.5mcg) has been approved in China as an anti-inflammatory reliever to be taken as-needed in response to symptoms to achieve asthma control in patients with mild asthma aged 12 years and older. |
| 2018-05-17 | AstraZeneca | Results New England Journal of Medicine publishes two trials for Symbicort as an anti-inflammatory reliever therapy ‘as needed’ in mild asthma astrazeneca.com ↗
AstraZeneca today announced results from the Phase III SYGMA trials 1 , 2 of Symbicort Turbuhaler (budesonide/formoterol) given as an anti-inflammatory reliever ‘as needed’ versus two different treatment regimens in patients with mild asthma. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2021-01-26 | AstraZeneca | Symbicort Turbuhaler approved in China as an anti-inflammatory reliever in mild asthma astrazeneca.com ↗ |
| 2018-05-17 | AstraZeneca | New England Journal of Medicine publishes two trials for Symbicort as an anti-inflammatory reliever therapy ‘as needed’ in mild asthma astrazeneca.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 44 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Terbutaline | “Group Terbutaline received 5 mg Terbutaline sulfate (2ml) and 3ml serum saline in nebulization repeated three times during 1 hour and every 4 hours during the first 24 hour protocol” NCT01944033 ↗39“Home use of nebulized Β2-agonist such as salbutamol 5 mg or terbutaline 10 mg for symptoms of intercurrent bronchospasm.” NCT00567476 ↗ “Short acting inhaled β2 agonists ( salbutamol and terbutaline)” NCT02515318 ↗ “Short acting inhaled β2 agonists ( salbutamol and terbutaline)” NCT02509299 ↗ “terbutaline inhalation suspension” NCT04527016 ↗ “Salbutamol, Terbutaline” NCT04433104 ↗ “Terbutaline (oral)” NCT02790047 ↗ |
| Known as | Bricasol | “terbutaline sulfate (Bricasol)” NCT00421122 ↗ |
| Known as | Terbutalin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00518141 ↗ |
| Known as | terbutaline sulfate | “Methacholine challenge tests to demonstrate therapeutic equivalence of terbutaline sulfate via different Turbuhaler(®) devices in patients with mild to moderate asthma:...” PMID 28232118 ↗ Feb 2017 |
| Known as | Terbutaline sulphate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02322788 ↗ |
| Action | Activate | “β2-adrenergic agonist” NCT00974051 ↗ |
| Route | Intravenous | “intravenous terbutaline” NCT00124995 ↗ |